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Functional Tricuspid Regurgitation (TR)NCT03700918

First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

A study testing DaVingiTR System in people with Functional Tricuspid Regurgitation (TR), run by Cardiac Implants LLC at 5 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Tricuspid Regurgitation (TR)
What is being tested?
DaVingiTR System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
5 sitesin 3 countries
Study dates
11 Nov 2017to Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe tricuspid regurgitation as defined by American Society of Echocardiography.
  • Symptoms of right ventricular failure despite appropriate medical therapy.
  • Multidisciplinary heart team (minimum of three physicians, including cardiology and cardiac surgery representatives) recommends tricuspid annuloplasty.
  • ≥18 years old at time of enrollment.
  • LVEF ≥ 30% within 45 days prior to index implant procedure.
  • PASP < 70 mmHg via right heart catheterization (subject at rest) within 90 days prior to index implant procedure.
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  • Right Ventricle TAPSE ≥ 13 mm within 45 days prior to index implant procedure.
  • Tricuspid valve annular diameter ≥ 40 mm as measured by baseline transthoracic echocardiography in the 4 chamber view within 45 days prior to index implant procedure.
  • Subject has provided written informed consent.
  • Subject agrees to comply with all required post-procedure follow-up visits, including device adjustment.

Who cannot join

  • Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV inotropes).
  • Severe Right Ventricle dysfunction.
  • Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
  • Previous tricuspid valve repair or replacement.
  • Transvalvular pacemaker or defibrillator lead is present.
  • Severe left-sided valve disease.
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  • Right-sided intra-cardiac mass, thrombus or vegetation is present.
  • Inability to properly guide the index implant procedure using Trans-esophagus echocardiography (e.g. acoustic window not adequate).
  • Subject requires chronic dialysis or renal replacement therapy.
  • MI or known unstable angina within the 30-days prior to the implant index procedure.
  • CVA within 3 months prior to index implant procedure.
  • Bleeding disorders, active peptic ulcer or GI bleed.
  • Contraindication to anticoagulation or antiplatelet medication, based on investigator's opinion.
  • Chronic oral steroid or immunomodulator use (≥ 6 months) or other condition that could impair healing response (e.g. cardiac sarcoidosis or other chronic inflammatory disease).
  • Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (life expectancy < 1 year), or lead to difficulties for subject compliance with study requirements.
  • Subject is enrolled in another investigational study which has not completed the required primary endpoint follow-up period (Note: patients involved in a long-term surveillance phase of another study are eligible for this study).
  • Female patients who are pregnant or lactating.

Trial locations and contacts

5 sites in 3 countries.

Nodar Kipshidze, MPH contact

1-917-370-6247

Nodar@cardiac-implants.com

5 sites in 3 countries

France3 sites, 3 recruiting

  • Hopital Bichat

    Paris

    Reza Farnoud, Dr., reza.farnoud.bch@aphp.fr

    Marina Urena Alcazar, MD

    Recruiting

  • Institut Mutualiste Montsouris

    Paris

    Imane Bagdadi, Imane.Bagdadi@imm.fr

    Christophe Caussin, MD

    Recruiting

  • Clinique Pasteur

    Toulouse

    Frederic Petit, fpetit@clinique-pasteur.com

    Didier Tchétché, MD

    Recruiting

Other trials in France

Czechia1 site, 1 recruiting

  • Na Homolce Hospital

    Prague

    Petr Moucka, Mgr, +420257272392, Petr.Moucka@homolka.cz

    Petr Neuzil, MD

    Recruiting

Other trials in Czechia

Israel1 site, 1 recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Ludmila Helmer, +97247772180, l_helmer@rambam.health.gov.il

    Kerner Arthur, MD

    Recruiting

Other trials in Israel

About this study

Official title: A First in Human Study to Assess Safety and Performance of the DaVingi™ System in the Treatment of Patients With Functional Tricuspid Regurgitation

The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

Read the detailed description

The annuloplasty ring is a small multi-element ring, consisting of an outer fabric layer, a pre-set stakes array and internal adjustment cord that can be adjusted at a later stage after the outer layer of the ring and stakes are encapsulated in new tissue growth. Once implanted, the ring is designed to serve as a foundation for promoting new annular tissue growth, effectively growing a new adjustable annulus around the valve.

the study has been approved by Institutional Review Boards and Competent Authorities in Czech Republic, France and Israel.

Being tested
DaVingiTR System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaVingiTR SystemDevice

    DaVingiTR Tricuspid valve annuloplasty repair device

Study groups in NCT03700918
Study groupRoleWhat they receive
DaVingiTR System Single ArmExperimentalsingle-arm, open label, multi-center study.
Receives: Device: DaVingiTR System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety- the incidence and severity of device-related serious adverse device effects (SADE)

    the incidence and severity of device-related serious adverse device effects (SADE) from time of index implant/ adjustment procedure through 30 days post-implant

    Measured: from time of index implant/ adjustment procedure through 30 days post-implant

  2. Device performance - Adjustment Device Technical Success: Rate of successful adjustment of the DaVingi™ TR ring at the tricuspid annulus, desired by physician

    Implant Device Technical Success and Adjustment Device Technical Success

    Measured: Immediately after procedure

Secondary outcomes (2)

  1. safety - Incidence of device-related major adverse cardiac events (MACE)

    Incidence of device-related major adverse cardiac events (MACE)

    Measured: 30 days post procedure

  2. safety - Rate of procedure-related serious adverse events (SAE)

    Rate of procedure-related serious adverse events (SAE)

    Measured: 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start11 Nov 2017
  3. Primary completionDec 2021 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
First in human
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700918
Sponsor's protocol ID
CLP-001
Status last verified
Nov 2021
First submitted
31 Dec 2017
Last updated
12 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing DaVingiTR System in people with Functional Tricuspid Regurgitation (TR), run by Cardiac Implants LLC at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Czechia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nodar Kipshidze, MPH (1-917-370-6247, Nodar@cardiac-implants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety- the incidence and severity of device-related serious adverse device effects (SADE) (time frame: from time of index implant/ adjustment procedure through 30 days post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03700918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.

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